Nevirapine Normon 200 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Nevirapine Normon 200 mg tablets EFG

Nevirapine

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Nevirapine Normon is and what it is used for
2. What you need to know before taking Nevirapine Normon
3. How to take Nevirapine Normon
4. Possible adverse effects
5. How to store Nevirapine Normon
6. Contents of the pack and other information

1. What Nevirapina Normon is and what it is used for

Nevirapina Normon belongs to a group of medicines called antiretrovirals, which are used in the treatment of infection with the Human Immunodeficiency Virus (HIV).

The active substance in this medicine is called nevirapine.

Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs in order to replicate. Nevirapine blocks the action of reverse transcriptase. By inhibiting this enzyme, Nevirapina Normon helps control HIV-1 infection.

Nevirapina Normon is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age. Nevirapina Normon must be taken in combination with other antiretroviral medicines. Your doctor will advise you which medicines are appropriate for you.

If Nevirapina has been prescribed for your child, please note that all the information in this leaflet applies to your child (in this case, whenever you read “you”, please replace it with “your child”).

2. What you need to know before starting to take Nevirapine Normon

• Do not take Nevirapine Normon − if you are allergic to nevirapine or to any of the other ingredients of this medicine (listed in section 6).

• if you have previously taken Nevirapine Normon and had to stop treatment because you experienced:

• severe skin rash

• skin rash with other symptoms such as:

• fever

• blistering

• mouth sores

• eye inflammation

• facial swelling

• general swelling

• difficulty breathing

• muscle or joint pain

• general malaise

• abdominal pain

• hypersensitivity reactions (allergy)

• liver inflammation (hepatitis)

• if you have severe liver disease

• if you have previously had to stop treatment with Nevirapine Normon due to changes in liver function

• if you are taking any medicine containing St. John's wort (Hypericum perforatum). This product may cause Nevirapine Normon to become ineffective.

• Warnings and precautions

• Consult your doctor or pharmacist before starting to take nevirapine.

During the first 18 weeks of treatment with Nevirapine Normon, it is very important that you and your doctor monitor for the development of liver or skin reactions. These reactions can become serious and may even be life-threatening. The risk of such reactions is greatest during the first 6 weeks of treatment.

The following patients are at higher risk of developing liver problems:

• women
• patients infected with hepatitis B or C
• abnormalities in liver function tests
• treatment-naïve patients with higher CD4+ cell counts at the start of treatment with Nevirapina Normon (women with more than 250 cells/mm³, men with more than 400 cells/mm³)
• pre-treated patients with detectable HIV-1 viral load in plasma and CD4+ cell counts above the threshold at initiation of treatment with Nevirapina Normon (women with more than 250 cells/mm³, men with more than 400 cells/mm³)

In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (AIDS-defining illnesses), signs and symptoms of inflammation from previous infections may appear shortly after starting anti-HIV treatment. These symptoms are believed to result from an improved immune response, enabling the body to fight infections that were previously present without apparent symptoms. If you notice any signs of infection, please inform your doctor immediately.

In addition to opportunistic infections, autoimmune disorders (a condition in which the immune system attacks healthy body tissue) may also occur after you have started taking medications for your HIV infection. Autoimmune disorders may appear many months after starting treatment. If you experience any symptoms of infection or other symptoms such as muscle weakness, weakness beginning in the hands and feet and progressing toward the trunk, palpitations, tremors, or hyperactivity, inform your doctor immediately so you can receive the necessary treatment.

Changes in body fat distribution may occur in patients receiving combination antiretroviral therapy. Consult your doctor if you notice changes in body fat (see section 4 “POSSIBLE ADVERSE EFFECTS”).

In some patients receiving combination antiretroviral therapy, a bone disease called osteonecrosis (death of bone tissue caused by reduced blood supply to the bone) may develop. Duration of combination antiretroviral therapy, use of corticosteroids, alcohol consumption, severe immune deficiency, and high body mass index may be among the many risk factors for developing this condition. Symptoms of osteonecrosis include stiffness in the joints, pain and discomfort—especially in the hip, knee, and shoulder—and difficulty moving. If you experience any of these symptoms, inform your doctor.

If you are taking nevirapine and zidovudine together, inform your doctor, as your white blood cell count may need to be monitored. Do not take nevirapine after exposure to HIV unless you have been diagnosed with HIV and your doctor has instructed you to do so.

Prednisone must not be used to treat nevirapine-associated rashes.

If you are taking oral contraceptives (e.g., “the pill”) or other hormonal methods of birth control while being treated with nevirapine, you must additionally use a barrier contraceptive method (e.g., condoms) to prevent pregnancy and transmission of HIV. If you are receiving postmenopausal hormone therapy, consult your doctor before taking this medication.

If you are taking or are prescribed rifampicin for the treatment of tuberculosis, inform your doctor before taking this medication with nevirapine.

Children and adolescents

Nevirapina Normon tablets can be used in:

• children aged 16 years or older
• children under 16 years of age:
• who weigh equal to or more than 50 kg
• or whose body surface area is greater than 1.25 m².

For smaller children, an oral liquid suspension formulation is available.

• Use of Nevirapina Normon with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription. Before starting Nevirapina Normon, inform your doctor about all other medicines you are taking. Your doctor may need to monitor whether your other medicines are still effective and may need to adjust their doses. Read carefully the package leaflet of all other anti-HIV medicines you are taking in combination with Nevirapina Normon.

It is especially important that you inform your doctor if you are taking or have recently taken:

• St. John’s wort (Hypericum perforatum, a herbal remedy used to treat depression)
• rifampicin (a medicine used to treat tuberculosis)
• rifabutin (a medicine used to treat tuberculosis)
• macrolides, e.g., clarithromycin (a medicine used to treat bacterial infections)
• fluconazole (a medicine used to treat fungal infections)
• ketoconazole (a medicine used to treat fungal infections)
• itraconazole (a medicine used to treat fungal infections)
• methadone (a medicine used to treat opioid addiction)
• warfarin (a medicine used to reduce blood clot formation)
• hormonal contraceptives (e.g., “the pill”)
• atazanavir (another medicine used to treat HIV infection)
• lopinavir/ritonavir (another medicine used to treat HIV infection)
• fosamprenavir (another medicine used to treat HIV infection)
• efavirenz (another medicine used to treat HIV infection)
• etravirine (another medicine used to treat HIV infection)
• rilpivirine (another medicine used to treat HIV infection)
• zidovudine (another medicine used to treat HIV infection)
• elvitegravir/cobicistat (another medicine used to treat HIV infection)

Your doctor will carefully monitor the effects of nevirapine and any of these medicines if you are taking them simultaneously.

If you are undergoing kidney dialysis, your doctor may consider it necessary to adjust the dose of nevirapine, as nevirapine may be partially removed from the blood by dialysis.

• Taking nevirapine with food and drinks

There are no restrictions on taking nevirapine with food and drinks.

• Pregnancy and breastfeeding

If you are pregnant, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Breastfeeding is not recommended for women living with HIV, because HIV infection can be transmitted to the baby through breast milk. If you are breastfeeding or considering breastfeeding, you must consult your doctor as soon as possible.

• Driving and using machines

While taking Nevirapina Normon, you may experience fatigue. Exercise caution when performing activities such as driving or operating machinery. If you experience fatigue, you should avoid potentially dangerous tasks such as driving or using machines.

• Nevirapine contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take Nevirapine

You must not take nevirapine on its own. It must be taken together with at least two other antiretroviral medicines. Your doctor will advise you on the appropriate medicines for you.

Always follow exactly your doctor's instructions for taking this medicine. In case of doubt, consult your doctor or pharmacist again.

Dosage:

The dose is one 200 mg tablet once daily for the first 14 days of treatment (the "lead-in" period). After 14 days, the usual dose is one 200 mg tablet twice daily.

It has been shown that the initial 14-day period reduces the risk of developing skin rash.

Since nevirapine must always be taken in combination with other antiretroviral medicines, you must carefully follow the instructions for these other medicines. These are provided in the package leaflets of those medicines.

Nevirapine is also available in an oral liquid suspension form. It is particularly suitable if:

• you have difficulty swallowing tablets
• in children weighing less than 50 kg
• in children whose body surface area is less than 1.25 m² (your doctor will determine body surface area)

You must continue taking nevirapine for as long as your doctor prescribes.

As explained earlier in the section 'Warnings and precautions', your doctor will monitor you with liver function tests and by watching for adverse effects such as rash. Depending on the results, your doctor may decide to interrupt or discontinue treatment with nevirapine. Likewise, your doctor may decide to restart treatment at a lower dose.

Nevirapine must only be taken orally. Do not chew the tablet. You may take nevirapine with or without food.

• If you take more nevirapine than you should
• Do not take more nevirapine than prescribed by your doctor and described in this leaflet. Currently, there is limited information on the effects of nevirapine overdose. Contact your doctor if you have taken more nevirapine than you should.

In case of overdose or accidental ingestion, contact the Toxicology Information Service, telephone: 91 562 04 20, and indicate the amount ingested.

• If you forget to take nevirapine

Try not to miss any doses.

If you realize you have forgotten a dose within 8 hours of the scheduled time, take the missed dose as soon as possible and then take the next dose at the usual time. If more than 8 hours have passed since the scheduled time, simply take the next dose at the usual time.

• If you interrupt treatment with Nevirapina Normon

Taking your doses at the prescribed times:

• greatly increases the effectiveness of your combination of antiretroviral medicines
• reduces the chances that HIV infection will become resistant to antiretroviral medicines

It is important that you continue taking Nevirapina Normon correctly as described above, unless your doctor advises you to stop treatment.

If you interrupt treatment with Nevirapina Normon for more than 7 days, your doctor will instruct you to restart with another initial 14-day period (as described above) before returning to the twice-daily dosing regimen.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

During HIV treatment, there may be an increase in body weight and in blood glucose and lipid levels. This may be partly related to improved health and lifestyle, and in the case of increased blood lipids, sometimes it may be due to HIV medicines themselves. Your doctor will monitor these changes.

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

As already mentioned in ‘Warnings and precautions’, the most important adverse effects of nevirapine are severe, life-threatening skin reactions and serious liver damage. These reactions occur mainly during the first 18 weeks of treatment with nevirapine. This is therefore an important period requiring close monitoring by your doctor.

If you notice any symptoms of a rash, inform your doctor immediately.

When a rash occurs, it is usually mild to moderate. However, in some patients, a blistering skin reaction may develop that can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis), and fatal cases have been reported. Most cases of both severe and mild/moderate rash occur during the first six weeks of treatment.

If a rash appears and you also feel generally unwell, you must stop treatment and contact your doctor immediately.

Hypersensitivity reactions (allergy) may occur. Such reactions may present as anaphylaxis (a severe type of allergic reaction) with symptoms such as:

• rash
• swelling of the face
• difficulty breathing (bronchospasm)
• anaphylactic shock

Hypersensitivity reactions may also present as a rash together with other adverse effects such as:

• fever
• blistering of the skin
• mouth sores
• eye inflammation
• swelling of the face
• general swelling
• difficulty breathing
• muscle or joint pain
• decrease in the number of white blood cells in the blood (granulocytopenia)
• general malaise
• serious liver or kidney problems (liver or kidney failure)

If you experience a rash and any of the other adverse effects associated with a hypersensitivity reaction (allergy), inform your doctor immediately. These reactions can be fatal.

Liver function abnormalities have been reported with the use of nevirapine. This includes some cases of liver inflammation (hepatitis), which may be sudden and severe (fulminant hepatitis), and liver failure, both of which can be fatal.

Inform your doctor if you experience any of the following clinical symptoms of liver damage:

• loss of appetite
• general malaise (nausea)
• vomiting
• yellowing of the skin (jaundice)
• abdominal pain

The following adverse effects have been reported in patients treated with nevirapine:

Very common (may affect more than 1 in 10 people):

• rash

Common (may affect more than 1 in 100 people):

• decrease in the number of white blood cells in the blood (granulocytopenia)
• allergic reactions (hypersensitivity)
• headache
• general malaise (nausea)
• vomiting
• abdominal pain
• liver inflammation (hepatitis)
• feeling of tiredness (fatigue)
• fever
• abnormalities in liver function tests

Uncommon (may affect up to 1 in 100 people):

• allergic reactions characterized by rash, facial swelling, difficulty breathing (bronchospasm), or anaphylactic shock
• decrease in the number of red blood cells (anaemia)
• yellowing of the skin (jaundice)
• severe and potentially life-threatening skin rashes (Stevens-Johnson syndrome/toxic epidermal necrolysis)
• urticaria
• fluid under the skin (angioedema)
• joint pain (arthralgia)
• muscle pain (myalgia)
• decreased blood phosphorus levels
• increased blood pressure

Rare (may affect up to 1 in 1,000 people):

• sudden and severe liver inflammation (fulminant hepatitis)
• drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)

When nevirapine has been used in combination with other antiretroviral medicines, the following events have also been reported:

• decrease in the number of red blood cells or platelets
• inflammation of the pancreas
• decrease or abnormalities in skin sensations

These effects are generally associated with other antiretroviral agents and may occur when nevirapine is used in combination with other agents; however, it is unlikely that these effects are due to nevirapine treatment.

Other adverse effects in children and adolescents

A decrease in white blood cells (granulocytopenia) may occur, more frequently in children. A decrease in red blood cells (anaemia), which may be related to nevirapine treatment, is also more frequent in children. As with rash symptoms, inform your doctor of any adverse effects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Nevirapine Normon

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging and on the blister after "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional information

Composition of Nevirapine Normon

• The active substance is nevirapine. Each tablet contains 200 mg of nevirapine.
• The other components are:
• microcrystalline cellulose
• lactose monohydrate
• povidone
• sodium carboxymethyl starch type A (from potato)
• colloidal silicon dioxide
• magnesium stearate.

Appearance of the product and contents of the pack

Nevirapine Normon is available as white or almost white, elongated, biconvex tablets, with a score line on one side and printed markings. Each pack contains 60 or 120 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of the latest revision of this leaflet: March 2026

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es